Prenatal Screening for Congenital Heart Diseases in the Antwerp Region

NCT ID: NCT04382222

Last Updated: 2020-05-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

2500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-06-01

Study Completion Date

2021-12-31

Brief Summary

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No systematic research has been done in the last 15 years on the accuracy of prenatal ultrasound of congenital heart diseases in Belgium. Nor are there any population-based studies available on this subject for Belgium. Based on the data of EUROCAT (European Surveillance of Congenital Anomalies) the investigators analyse prenatal diagnostic sensitivity of congenital heart diseases in the EUROCAT regions Antwerp (Flanders, Belgium)

Detailed Description

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Congenital heart defects are a leading cause of infant mortality with an incidence of 0,4-1,3% at birth. Although prenatal detection rates vary widely, morphological (structural) cardiac malformations are among the most frequently missed abnormalities by prenatal ultrasonography.

However, identifying fetal cardiac abnormalities early in pregnancy is essential. Early diagnosis allows extensive cardiac ultrasound, genetic testing and planning delivery in a paediatric-cardiac centre offering optimal neonatal care.

It also may allow the future parents to consider and decide for a termination of pregnancy in case of a severe fetal heart malformation with poor prognosis.

The investigator conducts a retrospective study on 2500 cases of congenital heart diseases over 20 years. Detailed data for this were made available by the EUROCAT Antwerp registry, a population-based database with controlled, reliable and robust data.

The study wants to reveal the prevalence and prenatal diagnostic sensitivity of congenital heart defects in the EUROCAT regions Antwerp (Flanders) and especially the evolution of the prenatal diagnostic rate over time.

In the second phase, a similar study in two adjacent regions, Hainaut (Wallonia, Belgium) and Groningen (The Netherlands) will follow.

On condition of correct statistic processing, these data will be suitable to compare the prevalence and to benchmark diagnostic rates of congenital heart defects in these three regions.

Conditions

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Congenital Heart Disease in Pregnancy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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prenatal ultrasound

prenatal cardiac ultrasound

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* All fetal congenital heart diseases registered in the Antwerp-EUROCAT database,
* In the period 1/1/1997-31/12/2017 period

Exclusion Criteria

* All cases of congenital heart diseases where the mother was under \<18 years old.
* All cases of congenital heart diseases were the parents did not allow inclusion in the EUROCAT registered.
* All cases of congenital heart diseases where the mother delivered outside the EC countries.
Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Universiteit Antwerpen

OTHER

Sponsor Role lead

Responsible Party

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Prof Yves Jacquemyn

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Paul Ramaekers, MD

Role: STUDY_CHAIR

University Antwerpen

Yves Jacquemyn

Role: STUDY_CHAIR

University Antwerpen

Locations

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University Hospital Antwerp

Edegem, Antwerp, Belgium

Site Status

Countries

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Belgium

Central Contacts

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Paul Ramaekers, MD

Role: CONTACT

+32477772234

Yves Jacquemyn, PhD

Role: CONTACT

+3238215945

Other Identifiers

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20/16/205 - 001126

Identifier Type: -

Identifier Source: org_study_id

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